You may not have heard that in the FDA Appropriations document that was released recently, they have budgeted $32 million dollars for the regulation, enforcement and follow up on dental laboratories. I was very pleased to hear this - not that I think we need more government intrusion in our lives, but I’m afraid that the wild-wild-west attitude that has permeated our industry has gotten out of hand. It’s become difficult to remain competitive and ensure our patients remain safe under the current conditions in our industry.

An excerpt from the U.S. Food and Drug Administration’s Justification of Estimates for Appropriations Committees reads:

Compliance and Enforcement – Center Activities
Base Amount: $32,203,309 (All BA)
The Compliance and Enforcement program ensures that devices and radiological products currently on the market remain safe and effective for consumers by enforcing regulations and laws to which regulated industry is subject. In FY 2009, FDA processed 776 device recalls, 32 of which were classified as Class I. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. FDA also issued 136 device warning letters in FY 2009. FDA continues to monitor and follow up on firms that received warning letters including dental laboratories and firms that produce infusion pumps, IV catheters, dermal fillers, surgical mesh, ear candles and temporomandibular joint (TMJ) implants. … CDRH’s Compliance and Enforcement program supports FDA’s import safety effort. CDRH is committed to an import safety program that helps assure that medical devices shipped to the United States meet FDA standards for safety and manufacturing quality and meet the needs of the growing global medical device market. CDRH continues to support commitments under the 2007 China memorandum of agreement (MOA) by providing medical device regulatory and capacity building training in China, India and Panama and is fulfilling additional commitments to capacity building by training FDA staff assigned to oversee FDA offices in India, Costa Rica, Europe, China and Jordan.

The $32 million dollars earmarked for this will likely be recovered through penalties and possible fees for dental labs. Especially in these conditions, nobody looks at this as an investment in public safety. This is a service and they will get their pound of flesh. How might this affect us? What will trigger an inspection and enforcement action?
 
Complaints
I suspect this will be the number one cause of a visit from the FDA. Complaints can come from a number of sources. Not surprisingly from disgruntled competitors. Labs who have undertaken the burden of compliance are unlikely to appreciate those who compete unfairly by being scofflaws. Especially those who counterfeit, price gouge or import. Dentist clients may file complaints if they are unhappy with something that happened between them and their lab. Perhaps someone substituted materials, such as using a generic zirconia in place of Lava, or a pressable in place of e.Max, or a casting in place of Captek. Manufacturers should rightly complain if they find a lab doing this. Frankly, I think this is way overdue. Disgruntled employees may also be responsible for complaints filed with the FDA. Whistleblowers are protected and encouraged, especially in healthcare.
 
Improper material disclosure and counterfeiting will be huge, and is an issue for every manufacturer. I’m sure they will applaud this measure.
 
Product Failures
In the event we experience another wide spread failure of some product, we can expect a great deal of FDA scrutiny. Material recalls and material traceability, or lack of them, can potentially lead to civil liability for both the dentist and the lab. The responsibility for recall identification and notification lies with the dental lab. Manufacturers will be quick to investigate any perceived product problems and documentation will be the only defense. They have a fiduciary duty to protect their brand and eliminate the possibility of counterfeiting, mishandling or the use of gray market materials. Labs caught doing this will most certainly be turned in to the FDA.  
 
New Registrations
Let’s face it, not too many labs have the R&D capability to develop and launch new products, so the likelihood of them filing 510k applications is low, but it does happen, and in some cases it should happen. During a medical device show seminar I sat in on recentl was all about overhauling the 510k approval process and I’m all for it. More scrutiny is needed, and unqualified people are being very cavalier about making things like apnea devices and surgical guides. Labs who register for repackaging and import/export will most likely get a visit as well, which I also think is completely appropriate.
 
I think this is perhaps the most important news I’ve heard in a long time. I think our industry needs some of this oversight, mainly because of greed and unscrupulous business people, but also due to the increased complexity of the work that we are doing and sophistication of our processes and materials. I for one am happy about this, and think it bodes well for our future.

About the author:Jackson is co-owner, vice president and general manager of Precision Dental Laboratory, DAMAS, in Montclair, California. He received his dental technology training in Southern California. He has lectured internationally on topics such as implant dentistry and laboratory management. Since opening Precision Dental Laboratory in 1981 the laboratory has expanded three times and employs 35 people.